{"description":"All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All adverse events (AEs) and disease related events (DREs) are integrated in above summaries.","eventGroups":[{"deathsNumAffected":12,"deathsNumAtRisk":98,"description":"Includes participants from all treatment arms that were administered AMG 820 1100 mg.","id":"EG000","otherNumAffected":97,"otherNumAtRisk":98,"seriousNumAffected":70,"seriousNumAtRisk":98,"title":"AMG 820 1100 MG"},{"deathsNumAffected":1,"deathsNumAtRisk":18,"description":"Includes participants from all treatment arms that were administered AMG 820 1400 mg.","id":"EG001","otherNumAffected":18,"otherNumAtRisk":18,"seriousNumAffected":10,"seriousNumAtRisk":18,"title":"AMG 820 1400 MG"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":98},{"groupId":"EG001","numAffected":4,"numAtRisk":18}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Parathyroid disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":98},{"groupId":"EG001","numAffected":10,"numAtRisk":18}],"term":"Periorbital oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Periorbital swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Photophobia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Uveitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Visual impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":98},{"groupId":"EG001","numAffected":6,"numAtRisk":18}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":98},{"groupId":"EG001","numAffected":9,"numAtRisk":18}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":98},{"groupId":"EG001","numAffected":5,"numAtRisk":18}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":98},{"groupId":"EG001","numAffected":3,"numAtRisk":18}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Duodenal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":98},{"groupId":"EG001","numAffected":7,"numAtRisk":18}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":98},{"groupId":"EG001","numAffected":5,"numAtRisk":18}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":98},{"groupId":"EG001","numAffected":3,"numAtRisk":18}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":98},{"groupId":"EG001","numAffected":5,"numAtRisk":18}],"term":"Face oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":98},{"groupId":"EG001","numAffected":10,"numAtRisk":18}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Hyperthermia malignant"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":98},{"groupId":"EG001","numAffected":3,"numAtRisk":18}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Hepatotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Portal vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Candida infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Mucosal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Alanine aminotransferase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":98},{"groupId":"EG001","numAffected":4,"numAtRisk":18}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":98},{"groupId":"EG001","numAffected":5,"numAtRisk":18}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Aspartate aminotransferase abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":58,"numAtRisk":98},{"groupId":"EG001","numAffected":12,"numAtRisk":18}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":98},{"groupId":"EG001","numAffected":5,"numAtRisk":18}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"International normalised ratio increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":98},{"groupId":"EG001","numAffected":5,"numAtRisk":18}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Liver function test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Troponin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":98},{"groupId":"EG001","numAffected":9,"numAtRisk":18}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hyperlipasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":98},{"groupId":"EG001","numAffected":3,"numAtRisk":18}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":98},{"groupId":"EG001","numAffected":8,"numAtRisk":18}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Vitamin D deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Myopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":3,"numAtRisk":18}],"term":"Colon cancer metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Colorectal cancer metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Non-small cell lung cancer metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Pancreatic carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":98},{"groupId":"EG001","numAffected":4,"numAtRisk":18}],"term":"Pancreatic carcinoma metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Rectal cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Akathisia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Facial paresis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":98},{"groupId":"EG001","numAffected":4,"numAtRisk":18}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Bladder spasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Nephrotic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":98},{"groupId":"EG001","numAffected":3,"numAtRisk":18}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Photosensitivity reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":98},{"groupId":"EG001","numAffected":4,"numAtRisk":18}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":98},{"groupId":"EG001","numAffected":5,"numAtRisk":18}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":98},{"groupId":"EG001","numAffected":4,"numAtRisk":18}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Venous thrombosis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Periorbital oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Uveitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Autoimmune pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Duodenal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Enterovesical fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Obstruction gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Autoimmune hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Bile duct obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Biliary colic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Hepatotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Immune-mediated hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Endocarditis staphylococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Klebsiella bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Liver abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Pelvic abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Staphylococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Hepatic enzyme increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Electrolyte imbalance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Colorectal cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Colorectal cancer metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Malignant pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Non-small cell lung cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Non-small cell lung cancer metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Pancreatic carcinoma metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Rectal cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Tumour flare"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Cerebellar infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Embolic cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Epilepsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Device dislocation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Nephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Nephrotic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Renal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Pharyngeal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Erythema nodosum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Rash generalised"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":98},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Rash maculo-papular"}],"timeFrame":"The TEAE timeframe was Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2. The median time frame is 122 days."}